To evaluate the safety of the combination of methadone and an atypical antipsychotic in PICU patients.
This was a retrospective observational cohort pilot study in a single-center PICU in an academic children's hospital. Children 1 month to 18 years of age were included if they received methadone, were then initiated on an atypical antipsychotic (i.e., quetiapine or risperidone), and had EKG monitoring before and after medication initiation.
Prolongation of the corrected QT (QTc) interval occurred in 5 of the 34 included patients when an atypical antipsychotic was added to methadone. Of the 5 patients who had a prolonged QTc interval, 4 (80%) were older than 12 years and had a median weight of 91.3 kg. There were statistical differences between age and weight when comparing patients who experienced QTc prolongation, but no differences in sex, ethnicity, electrolyte deficiencies, number of additional QTc-prolonging medications, and number of additional drug-drug interactions were identified. When comparing atypical antipsychotics, 9.5% of patients receiving risperidone had a prolonged QTc interval, versus 23% of patients receiving quetiapine (p = 0.04). The net change in QTc interval after initiation of methadone was 0.19 milliseconds (IQR -3, 15), which increased after atypical antipsychotic initiation to 4 milliseconds (IQR -16, 15).
Our pilot trial suggests there is no clinically significant difference in incidence of QTc prolongation with addition of atypical antipsychotics to methadone.
Our pilot trial suggests there is no clinically significant difference in incidence of QTc prolongation with addition of atypical antipsychotics to methadone.Ambrisentan, an endothelin receptor antagonist FDA-approved for the treatment of pulmonary arterial hypertension in adult patients, lacks an acceptable pediatric dosage form. The objective of this investigation was to determine the stability of an extemporaneously compounded ambrisentan suspension.
Ambrisentan suspension was compounded to a concentration of 1 mg/mL using commercially available suspending agents. The suspension was then evenly split into 2 plastic amber prescription bottles. One bottle was stored at room temperature and under continuous fluorescent light while the other bottle was stored under refrigeration and protection from light. A fast and selective reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the analysis of ambrisentan. HPLC analysis was performed on samples withdrawn from the stock bottles at predetermined time intervals, up to 90 days.
The developed HPLC method enabled the elution and detection of ambrisentan peak at 4.4 minutes. HPLC analysis revealed that all samples from both storage conditions retained &gt;90% potency throughout the study timeframe. There were no signs of any ambrisentan breakdown products on HPLC analysis. Color and odor of the final product was also consistent throughout the 90-day storage period.
Ambrisentan suspension, compounded to 1 mg/mL, is stable at room temperature or under refrigeration for up to 90 days.
Ambrisentan suspension, compounded to 1 mg/mL, is stable at room temperature or under refrigeration for up to 90 days.An adverse consequence of primarily soybean oil-based parenteral nutrition is the development of intestinal failure-associated liver disease (IFALD), defined as bilirubin ? 2 mg/dL. Fish oil-containing lipid emulsion products, such as soybean oil, medium-chain triglycerides, olive oil, fish oil lipid injectable emulsion (SMOF-ILE), have been shown to be beneficial in patients at risk of developing IFALD. This study aimed to review the safety profile of SMOF-ILE and soybean oil-based lipid injectable emulsion (SO-ILE) in regard to liver function and cholestasis in the pediatric and neonatal population.
A retrospective review was performed for patients who received SO-ILE or SMOF-ILE over a 3-year period. Patients &lt; 18 years of age who received at least 2 weeks of either product were included. The primary endpoints were 2 consecutive bilirubin readings ? 2 mg/dL that were separated by at least 1 week and time to first bilirubin ? 2 mg/dL. Secondary endpoints included assessment of select laboratory values (i.e., aspartate aminotransferase, alanine aminotransferase, triglycerides, serum creatinine, serum sodium, coagulation laboratory test, albumin) up to 6 months while on intravenous lipid products. Ursodiol use and mortality were also noted.
There was a higher prevalence of IFALD in pediatric patients receiving SO-ILE than those who received SMOF-ILE (32% vs 12%, p = 0.03). There was no detectable difference in the time it took for IFALD to develop (19 days vs 15 days, p = 0.08).
In our cohort of pediatric and neonatal patients, the incidence of IFALD was higher with SO-ILE than with SMOF-ILE.
In our cohort of pediatric and neonatal patients, the incidence of IFALD was higher with SO-ILE than with SMOF-ILE.Preterm infants often require caffeine for the treatment of apnea. While the maintenance dose of caffeine citrate is usually administered once daily per FDA labeling, many providers administer the maintenance dose in two divided doses. This study evaluated the effectiveness of a twice daily dosing regimen of caffeine for apnea of prematurity.
This was a retrospective analysis conducted from 2013-2018 that included preterm infants who received caffeine that was dosed both once and twice daily respectively. The primary outcome of our study was a composite of the number of apneic and bradycardic events for five 24-hour periods prior to switching to twice daily dosing of caffeine and five 24-hour periods after switching to twice daily dosing of caffeine.
The median five-day average incidence of apnea and bradycardia during the once and twice daily dosing periods was 6.2 events and 6.4 events respectively (p=0.09).
There is little benefit of twice daily dosing of caffeine for apnea of prematurity.
There is little benefit of twice daily dosing of caffeine for apnea of prematurity.Cystic fibrosis (CF) patients and caregivers are impacted by the number of pharmacological agents and unique administration needs; however, no data currently assesses how medication regimen complexity impacts clinical outcomes in this population. The objective of this study is to evaluate if an association exists between increased medication regimen complexity and clinical endpoints in pediatric patients with CF.
This retrospective analysis included all pediatric patients with CF (ages 5-20 years) with at least 2 pharmacist encounters and acceptable pulmonary function tests at our pediatric pulmonary clinic during 2017. Each patient's medication regimen was scored using the validated Medication Regimen Complexity Index (MRCI) tool. https://www.selleckchem.com/products/sn-52.html The primary outcome was the correlation between MRCI score and lung function. Secondary endpoints included growth, number of infections requiring antibiotics, and hospitalizations.
MRCI scores of the 113 included patients ranged from 2 to 101 points. A negative correlation was found between initial and final MRCI score and initial and final forced expiratory volume in 1 second (FEV; = -0.